title: Evaluation of a CYP2C19 genotype panel on the GenMark eSensor® platform and the comparison to the Autogenomics Infiniti™ and Luminex CYP2C19 panels.
abstract: BACKGROUND
  CYP2C19 variants have been demonstrated to play an important role in determining response to clopidogrel and outcomes while on clopidogrel therapy. Predicting patient response through pre-therapeutic genotyping may therefore guide selection of antiplatelet therapy.
  
  
  METHODS
  CYP2C19 genotypes were determined for 111 samples with the eSensor and compared with the Autogenomics expanded CYP2C19 panel, Luminex reagents, and bi-directional sequencing. Samples were obtained from the University of Chicago, ARUP Laboratories, and the Coriell repositories. Reproducibility studies were performed with 5 DNA samples with known CYP2C19 genotypes.
  
  
  RESULTS
  Complete concordance was observed for all samples and all platforms. DNA concentrations as low as 0.05 ng/μl may be used on the eSensor platform. There was 100% reproducibility observed with 2.5% incidence of invalid tests.
  
  
  CONCLUSIONS
  The eSensor CYP2C19 genotyping assay is accurate and compares well with 2 current commercial platforms. With a relatively rapid turn-around time of ~4 h and a high rate (97.5%) of valid tests, the eSensor can be translated into clinical use to identify slow and rapid metabolizers of clopidogrel who may benefit from alternate therapy or unconventional dosing of clopidogrel. An observed limitation of the eSensor is a maximum capacity of 24 tests/run.
authors.affiliation: Department of Pathology, Pritzker School of Medicine, University of Chicago, Chicago, IL 60637-1470, USA.
authors.forename: Christine C
authors.initials: CC
authors.lastname: Lee
authors.forename: Gwendolyn A
authors.initials: GA
authors.lastname: McMillin
authors.forename: Nikolina
authors.initials: N
authors.lastname: Babic
authors.forename: Roberta
authors.initials: R
authors.lastname: Melis
authors.forename: Kiang-Teck J
authors.initials: KT
authors.lastname: Yeo
mesh_terms: D000483:Alleles; D001189:Aryl Hydrocarbon Hydroxylases / Q000235:genetics*; D002460:Cell Line; D065731:Cytochrome P-450 CYP2C19; D023281:Genomics; D060005:Genotyping Techniques / Q000379:methods*; D006801:Humans; D020641:Polymorphism, Single Nucleotide / Q000235:genetics
chemical_list: D001189:Aryl Hydrocarbon Hydroxylases; C045793:CYP2C19 protein, human; D065731:Cytochrome P-450 CYP2C19